CONVENTIONAL VS HIGH PROTEIN INTAKE RATE TO ELBW NEONATE

描述(改编自申请人的描述)：本报告的目的 项目是确定极端早期和最大限度的营养 低出生体重(ELBW)婴儿。目前，普遍的做法是限制 极低出生体重儿出生后第1天给予底物注射。这 导致出生后营养不良，导致短期生长障碍 可能会对长期增长和发展产生影响。我们假设 对于出生后24-48小时的极低出生体重婴儿来说，一种氨基酸 给药率可与同一时间交付给胎儿的相当 受孕后年龄(“高”摄入量)在以下方面既安全又有效 与传统的(低摄入量)氨基酸相比，蛋白质的增加更快 产酸率，一般可避免早期产后营养不良 从目前的营养策略来看。ELBW婴儿将在#年随机进行 生命的前12小时静脉注射氨基酸为1克/公斤/天，而不是3克/公斤/天 24-48小时后进行的实验性蛋白质代谢研究 肠外营养。蛋白质平衡将由氮平衡决定 和稳定同位素方法学。安全性将通过血浆氨基酸进行评估 和血尿素氮浓度。葡萄糖和甘油周转率 测量将评估葡萄糖、脂肪和氨基酸的交互作用。 酸对蛋白质代谢的影响。总非蛋白质能量摄入对健康的影响 蛋白质平衡也将被确定。将使用亮氨酸动力学研究 为了确定调节蛋白质合成、分解和释放的机制 不同氨基酸摄入量的人群中的氧化作用。这将是 出生后立即对ELBW新生儿进行的第一项随机研究，包括 氨基酸摄入量高达3g/kg/d，接近胎儿的摄入量 氨基酸递送率和理论上是理想的极低出生体重儿 氨基酸摄入量。如果这项研究证明了这种疗法的安全性和有效性 氨基酸摄入，这将为更大规模的临床试验奠定基础 早期较高的氨基酸摄入量对住院时间的影响 出生后短期和长期的生长和神经发育结果。

DESCRIPTION (Adapted from applicant's description): The purpose of this project is to determine the optimal early and maximal nutrition in extremely low birth weight (ELBW) infants. Currently, it is common practice to limit substrate administration to ELBW neonates in the first days after birth. This results in postnatal malnutrition that causes short-term growth failure that may have consequences for long-term growth and development. We hypothesize that for ELBW infants in the first 24-48 hours of life, an amino acid administration rate comparable to that delivered to the fetus at the same post-conceptional age ("high" intake) is both safe and efficacious in terms of enhanced protein accretion when compared to conventional ("low" intake) amino acid delivery rates, and can avoid the early postnatal malnutrition commonly seen with current nutritional strategies. ELBW infants will be randomized in the first 12 hours of life to 1 versus 3 g/kg/d intravenous amino acids and experimental protein metabolism studies performed after 24-48 hours on parenteral nutrition. Protein balance will be determined by nitrogen balance and stable isotope methodologies. Safety will be assessed by plasma amino acid and blood urea nitrogen concentrations. Glucose and glycerol turnover rate measurements will assess the interactive effects of glucose, fat, and amino acids on protein metabolism. The effect of total non-protein energy intake on protein balance will also be determined. Leucine kinetic studies will be used to determine the mechanisms regulating protein synthesis, breakdown and oxidation in this population at different amino acid intakes. This will be the first randomized study in ELBW neonates immediately after birth that includes an amino acid intake as high as 3 g/kg/d, an intake that approaches the fetal amino acid delivery rate and that theoretically is the desired ELBW infant amino acid intake. If this study demonstrates the safety and efficacy of this amino acid intake, it will set the stage for larger clinical trials on the effect of early, higher amino acid intake on duration of hospitalization, short- and long-term postnatal growth, and neurodevelopmental outcome.